with advice not to undertake activities that demanded more than 70% of participants perceived energy envelopes

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when I had pacing therapy (from one of the coauthors of the manual), there was no mention of a 70% limit: it seems a guaranteed way of making sure you don't increase what you can do overall. Or have I misunderstood something?

My letter to Liam Donaldson (chief medical officer at the time) is linked there also, as is a press release and other information which may be useful to people. Although these are almost historical documents- they still hold up as problems in the PACE trial today (although additional key problems have been identified since), and provide an indication of how long objections to this trial have been going on, as well as possible discrepancies in PACE's final publication of their study in the Lancet.

How bloody depressing. Not only have we got to live with the day to day struggle of living a life like swimming through treacle, but now we have to fight all over again to explain to people who have watched the telly today that this is a chronic, debilitating, neuro-endo-immune condition and not just a bad day at the office!

I haven't been following this from the start, so forgive me if this is already accepted protocol, but it seems as though the PACE thing, the psycho lobby and the Lightning Process all release press releases to the media in a very sensationalist one-sided way. If we released a press release to the media announcing incredible breakthroughs with XMRV, presumably the governments have no way of stopping the press reporting on them? It seems as though the biomedical side is often writing letters in response to bad media rather than putting out very strong good media?

Unfortunately I think in these days of the media-led society, lobbying governments can only take us so far, but getting the truth out in the media (for example, inthe UK, if we could find someone at the Guardian willing to dig under the cover of these new announcements a bit) will force the governments to take notice because of public opinion.

The authors consider these to be “moderate improvements”, which is an appropriate conclusion. Compared with specialised medical care alone, CBT plus specialised medical care improved fatigue scores by 3.4 points on a 33-point scale, while GET plus specialised medical care improved scores by 3.2 points. Physical function score improvements were 7.1 for CBT and 9.4 for GET on a 100-point scale.

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Which sums it up nicely, though you could argue that 3.4 point improvement on a 33-point scale etc is pretty poor. Those stark figures do show just how limited an impact the therapies have made. Given that

CBT was done on the basis of the fear avoidance theory of chronic fatigue syndromeand
GET was done on the basis of deconditioning and exercise intolerance theories of chronic fatigue syndrome

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and the results are so limited, you have to question the theories that CBT and GET are based on.

I think the PACE trial has provided powerful evidence that the biopsycosocial model is deeply flawed, from the greatest promoters of this model. Nice. We should be making the most of this evidence in due course.

Similarly, although 16% of the APT group and 15% of the SMC group were within normal ranges for both primary outcomes at the end of the study, 30% of the CBT group and 28% of the GET group reached this goal.

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Not sure what normal for primary outcomes is but note that 70% of the CBT group did not reach 'normal'. What is a normal Chalder scale reading (ie healthy people would have), moderately ill and severely ill Chalder scale reading?

Although the findings show better efficacy of CBT and GET compared with APT, these treatments were still "only moderately effective," emphasizing that research into more effective treatments is needed.

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Note that this was the aim of the study

"The aim of treatment was to change the behavioural and cognitive factors assumed to be responsible for perpetuation of the participant’s symptoms and disability."

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YOu can come to a couple potential conclusions about this: (a)their assumption - that behavioral and cognitive factors are responsible for the symptoms and disability in this disorder is false - since their treatments had only moderate effects on CFS (and only on a subset of individuals) and/or b) they don't have particularly effective ways of addressing those factors.

Trial information
Please note that the PACE trial closed to recruitment on 28 November 2008.

17 February 2011 update: PACE treatment manuals available

Treatment manuals (all PDFs): The treatment manuals are available free of charge for down-loading, so long as no changes are made to the manuals. Any use of these manuals should acknowledge the PACE trial (www.pacetrial.org).These manuals were used in the PACE trial by healthcare professionals and participants to support PACE trial treatments, which are described in the manuals. The results regarding efficacy and safety of these treatments are not yet published, but will be reported in the main paper of the PACE trial.

These treatments should only be delivered by appropriately qualified healthcare professionals, who have received appropriate training and continued supervision in their use. The treatments described were not designed to be stand-alone self-help approaches. No responsibility is accepted by the authors for the application of treatments described in these manuals outside of the PACE trial. The PACE trial team are unable to respond to queries or comments regarding the use of these manuals or the treatments described.

March 2010 update: Data collection for the one year follow up has now been completed. The trial data is currently being analysed in preparation for publication of the findings. Further information regarding publication will be posted here when available.

Given the harm that's been done to patients through the promotion the the psychosocial approach to CFS, they'd better come up with something damn near curative. Moderately alter questions for a fatigue questionnaire? I'd be pretty pissed.

I'm looking more and more at this and finding that the results were really very poor; there is very little indication of significant functional improvement.

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You or others may not know or may have forgotten: when they initially applied for funding, they had actometers at the end or at the start. Improvements on that could have carried some weight. However, then they decided to drop them. I think it was they may have heard what happened with the Prins study which was known about in 2002 - see http://www.biomedcentral.com/1471-2377/7/6/comments#280543 Or maybe the Friedberg study did it.

Abstract
One can classify ways to establish the interpretability of quality-of-life measures as anchor based or distribution based. Anchor-based measures require an independent standard or anchor that is itself interpretable and at least moderately correlated with the instrument being explored. One can further classify anchor-based approaches into population-focused and individual-focused measures. Population-focused approaches are analogous to construct validation and rely on multiple anchors that frame an individual's response in terms of the entire population (eg, a group of patients with a score of 40 has a mortality of 20%). Anchors for population-based approaches include status on a single item, diagnosis, symptoms, disease severity, and response to treatment. Individual-focused approaches are analogous to criterion validation. These methods, which rely on a single anchor and establish a minimum important difference in change in score, require 2 steps. The first step establishes the smallest change in score that patients consider, on average, to be important (the minimum important difference). The second step estimates the proportion of patients who have achieved that minimum important difference. Anchors for the individual-focused approach include global ratings of change within patients and global ratings of differences between patients. Distribution-based methods rely on expressing an effect in terms of the underlying distribution of results. Investigators may express effects in terms of between-person standard deviation units, within-person standard deviation units, and the standard error of measurement. No single approach to interpretability is perfect. Use of multiple strategies is likely to enhance the interpretability of any particular instrument.

You or others may not know or may have forgot: when they initially applied for funding, they had actometers at the end or at the start. Improvements on that could have carried some weight. However, then they decided to drop them. I think it was they may have heard what happened with the Prins study which was known about in 2002 - see http://www.biomedcentral.com/1471-2377/7/6/comments#280543 Or maybe the Friedberg study did it.

You or others may not know or may have forgot: when they initially applied for funding, they had actometers at the end or at the start. Improvements on that could have carried some weight. However, then they decided to drop them. I think it was they may have heard what happened with the Prins study which was known about in 2002 - see http://www.biomedcentral.com/1471-2377/7/6/comments#280543 Or maybe the Friedberg study did it.

I was going to ask about that. I saw that - something else to mention in the article..Thanks

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Forgot to say: the participants still wore them before the trial. So there was no extra costs involved. Using 5m (US$8m) of taxpayers' money and they avoid using something which would give some hard data.

The only objective measure is the 6 minute walking ability test. Can anyone get some data from healthy controls from anywhere or normative data. One could do a t-test and compare against the results. The "best" result was 379m which doesn't seem that far - it's less than 1 lap of a 400m athletics track (it translates to an average speed of 3790m/hour - it's not saying they could do that amount of course in 1 hour).